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Symptom Support During Chemotherapy: A Mixed Method Study in Adult Patients With Cancer

Symptom Support During Chemotherapy: A Mixed Method Study in Adult Patients With Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02298972
Enrollment
143
Registered
2014-11-24
Start date
2014-10-31
Completion date
2015-09-30
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Chemotherapy

Brief summary

This study evaluates the value of a nursing symptom support en selfmanagement intervention for adult patients with cancer treated with chemotherapy. Using a prospective sequential design with a comparison group who receives standard care and a (later) intervention group who gets the nursing intervention, we will evaluate the effect of this nursing intervention on overall symptom distress (primary outcome) and other measures of symptom burden, self-efficacy, outcome expectations and self-care. By conducting sem-structured interviews with some participants of the intervention group, we will study the patient experience of the intervention.

Interventions

BEHAVIORALNurse support and selfmanagement intervention

Sponsors

Flemish League Against Cancer
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients starting first line treatment with (intravenous) chemotherapy * Ambulatory patients or patients who receive their treatment during short hospital stays * Regardless of type of cancer, treatment or treatment intention (curative or palliative) * Who understand sufficiently Dutch to fill out questionnaires * Who sign informed consent for their participation in the study

Exclusion criteria

* Oral anticancer treatment * Concomitant chemoradiotherapy * Breast cancer patients who receive nurse counseling throughout their therapy * Experimental therapy in the context of a clinical trial

Design outcomes

Primary

MeasureTime frameDescription
Overall symptom distressLongitudinal, during first 3 months after start of treatmentSummed symptom distress as self-reported on the Symptom Burden Questionnaire
Overall symptom severityLongitudinal, during first 3 months after start of treatmentSummed symptom severity as self-reported on the Symptom Burden Questionnaire

Secondary

MeasureTime frameDescription
Total self-efficacy scoreDay 43 of treatment (+/- 1 week)Outcome will be measured by a self-report questionnaire: shortened version of the Cancer Behavior Inventory
Total outcome expectations scoreDay 43 of treatment (+/- 1 week)Outcome will be measured by a self-report questionnaire
Total self-care scoreDay 85 of treatment (+/- 1 week)Outcome will be measured by a self-report questionnaire: shortened version of the Leuven- Patient Self-care during chemotherapy scale

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026